Nanovis Intervertebral Body Fusion System And Forticore(R)

Intervertebral Fusion Device With Bone Graft, Lumbar

NANOVIS LLC

The following data is part of a premarket notification filed by Nanovis Llc with the FDA for Nanovis Intervertebral Body Fusion System And Forticore(r).

Pre-market Notification Details

• Device ID: K161485
• 510k Number: K161485
• Device Name: Nanovis Intervertebral Body Fusion System And Forticore(R)
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: NANOVIS LLC 5865 EAST STATE RD. 14 Columbia City, IN 46725
• Contact: Matthew Hedrick
• Correspondent: Karen E. Warden; BACKROADS CONSULTING INC. PO BOX 566 Chesterland, OH 44026 2141
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-05-31
• Decision Date: 2016-09-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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